FDA Approves First Dual Bronchodilator COPD Treatment
The FDA announced its approval of Anoro Ellipta, a new dry powder inhaler developed for daily use to treat Chronic Obstructive Pulmonary Disease (COPD). It is a combination of umeclidinium bromide and vilanterol, both bronchodilators. It is so new that GlaxoSmithKline has yet to publish pharmaceutical information on this product.
The FDA committee that approved the drug was divided in their decision due to concerns about some of the side effects that could impact cardiac functions. The clinical trial was run using a group of 2,400 patients, and the results yielded a significant number of side effects. Some of these included pharyngitis, sore throat, sinus infections, lower respiratory infection, constipation, and diarrhea. Rare side effects included urinary tract infections, toothache, arthralgia, nausea, and vertigo.
The medication will be launched with a warning lable stating that this medication should not be used for asthma - as one of the two primary medications, vilanterol, increases the risk of asthma-related death.
This past summer, GlaxoSmithKline experienced success with Breo Ellipta, the first once-daily inhaler for use in COPD. Breo Ellipta has a corticosteroid, which carries more long-term effects than the two bronchodilators in Anoro. Use of corticosteroids puts patients at risk of potentiating infections.
COPD is most commonly caused by smoking and includes conditions such as chronic bronchitis and emphysema. It is also the third leading cause of death in the United States. Anoro opens the airways by affecting the muscles in the airway walls, to help them open and stay open to allow for increased air flow. It is the first non-steroidal once-daily inhaler for this use.
Other treatments for COPD include oral steroids, phospdiesterase-4 inhibitors, theophylline and antibiotics. If these treatments begin to lose efficacy, surgery becomes a consideration.
Original Source Dated January 3, 2014: http://blogs.delawareonline.com/delawareinc/2014/01/03/fda-approves-treatment-for-copd/?nclick_check=1